Duns Number:688817949
Device Description: NON-WOVEN THIGH SLEEVE (Small [DS011] 2ea, Medium [DS012] 2ea, Large [DS013] 2ea, X-Large NON-WOVEN THIGH SLEEVE (Small [DS011] 2ea, Medium [DS012] 2ea, Large [DS013] 2ea, X-Large [DS014] 2ea)NON-WOVEN CALF SLEEVE (Small [DS021] 2ea, Medium [DS022] 2ea, Large [DS023] 2ea, X-Large [DS024] 2ea)NON-WOVEN BOOT SLEEVE (Medium [DS041] 2ea)NON-WOVEN FOOT SLEEVE (Medium [DS031] 2ea)
Catalog Number
-
Brand Name
DVT-SERIES
Version/Model Number
DVTNWSET
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203016,K203417
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
7494b90d-d52b-4732-aa1e-edf510c85a1c
Public Version Date
June 30, 2021
Public Version Number
1
DI Record Publish Date
June 22, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |